[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TICAROS Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100629322","phase-1-study-of-safety-and-efficacy-of-tc011-in-the-relapsedrefractory-large-b-cell-non-hodgkin-lymphoma-patients-100629322",false,"NCT07473167","Study of Safety and Efficacy of TC011 in the Relapsed\u002FRefractory Large B Cell Non-Hodgkin Lymphoma Patients","A Multi-center, Single Arm, Open-label Phase 1\u002F2 Clinical Trial to Evaluate Safety, and to Explore Efficacy of TC011(CD19 Targeted CAR-T) in the Relapsed\u002FRefractory Large B Cell Non-Hodgkin Lymphoma Patients","TC011","Inclusion Criteria:\n\nSubjects must meet all criteria including:\n\n* ≥19 years old, ECOG 0-2, life expectancy ≥12 weeks\n* Histologically confirmed B-cell lymphoma (WHO 2017)\n* Relapsed\u002Frefractory after ≥2 prior lines of systemic chemotherapy\n* ≥1 measurable lesion (longest diameter ≥1.5 cm)\n* Adequate organ, and pulmonary function\n* LVEF ≥40%\n* Able to undergo leukapheresis\n* For subjects of childbearing potential: agreement to use effective contraception for ≥6 months after TC011 infusion\n\nExclusion Criteria:\n\n* Unresolved ≥Grade 2 toxicities from prior therapy\n* Malignancy within 2 years except specified exceptions\n* Significant cardiac disease within 6 months\n* CNS involvement by lymphoma\n* Active HBV, HCV, HIV, syphilis\n* Rapidly progressing disease per investigator\n* Major surgery requiring general anesthesia within 4 weeks\n* Active or uncontrolled infection\n* Prior therapies such as anti-CD19 agents, adoptive T-cell therapy, gene therapy, allogeneic HSCT\n* Use of other investigational agents, immunosuppressants within protocol-specified windows\n* Pregnancy or breastfeeding\n* Hypersensitivity to study drug components\n* Leukapheresis-specific exclusions (recent chemotherapy, steroids, immunosuppressants)","ALL","19 Years",{"count":20,"type":21},98,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a multi-center, phase I\u002FII study to determine the safety and efficacy of TC011(CD19 Targeted CAR-T) in adult patients with relapsed or refractory large B-cell non -hodgkin lymphoma.",[28,29,30,31,32,33],"Relapsed Large B-cell Lymphoma","Refractory Large B-cell Lymphoma","Diffuse Large B-cell Lymphoma (DLBCL)","High-grade B-cell Lymphoma (HGBL)","Transformed Follicular Lymphoma (TFL)","Primary Mediastinal Large B-cell Lymphoma (PMBCL)",[15,35,36,37],"CAR-T","Chimeric antigen receptor","CLIP","RECRUITING","2026-03-10",{"date":41,"type":42},"2026-03-16","ACTUAL",{"date":44,"type":42},"2023-08-03",{"date":46,"type":21},"2028-03-10",{"name":48,"class":49},"TICAROS Co., Ltd.","INDUSTRY",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100620643","phase-2-efficacy-and-safety-of-tc011-in-relapsed-or-refractory-follicular-lymphoma-100620643","NCT07360288","Efficacy and Safety of TC011 in Relapsed or Refractory Follicular Lymphoma","A Multi-center, Single-arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of TC011 in Patients With Relapsed or Refractory Follicular Lymphoma","TC011_FL_201","Inclusion Criteria:\n\n1. Ability to provide written informed consent.\n2. Age ≥19 years at the time of screening.\n3. Histologically confirmed follicular lymphoma Grade 1, 2, or 3a according to WHO 2017 classification.\n4. Relapsed or refractory disease after at least two prior systemic therapies including rituximab.\n5. ECOG performance status ≤2.\n6. Life expectancy ≥12 weeks.\n7. At least one measurable lesion (long diameter ≥1.5 cm).\n8. Adequate hepatic, renal, hematologic, pulmonary, and cardiac function.\n9. Eligible for leukapheresis and successful manufacture of TC011.\n10. Agreement to use effective contraception for at least 6 months after TC011 infusion.\n\nExclusion Criteria:\n\n1. Histologic transformation to diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.\n2. Unresolved ≥Grade 2 toxicity from prior anticancer therapy (excluding hematologic abnormalities).\n3. Active or prior malignancy within 2 years, except adequately treated non-melanoma skin cancer or carcinoma in situ.\n4. Clinically significant cardiovascular disease within 6 months prior to screening.\n5. Active central nervous system involvement by lymphoma.\n6. Active uncontrolled infection, including HBV, HCV, HIV, or syphilis (protocol-defined exceptions apply).\n7. Active autoimmune or inflammatory neurologic disease.\n8. Rapidly progressive disease requiring urgent therapy.\n9. Prior treatment with anti-CD19 therapy, adoptive T-cell therapy, gene therapy, or allogeneic stem cell transplantation.\n10. Major surgery within 4 weeks prior to screening.\n11. Use of investigational agents within 4 weeks prior to screening.\n12. Known hypersensitivity to components of TC011.\n13. Pregnant or breastfeeding women.",{"count":60,"type":21},40,[25],"This Phase II, multi-center, single-arm, open-label study evaluates the efficacy and safety of TC011, a CD19-targeted CAR-T cell therapy, in adult patients with relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a).\n\nThe primary endpoint is objective response rate (ORR) assessed by independent review using the Lugano 2014 classification.",[64],"Follicular Lymphoma (FL)",[66,35,67,68,69],"Follicular Lymphoma","CD19","Adoptive Cell Therapy","Immunotherapy","NOT_YET_RECRUITING","2026-01-14",{"date":73,"type":42},"2026-01-22",{"date":75,"type":21},"2026-03-01",{"date":77,"type":21},"2030-02-28",{"name":48,"class":49},""]